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Tests treatment safety and results for Prostate Cancer
Official title Effectiveness of Focal Therapy in Men With Prostate Cancer
ClinicalTrials.gov ID: NCT06223295
What this study is testing
- What it's testing
- In the Netherlands, most men with prostate cancer (PCa) are treated with radical whole-gland treatment, i.e. prostatectomy or radiotherapy.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older, men only
You may be able to join if
- Gleason score of 7 (3 + 4 or 4 + 3; ISUP grade 2/3)
- PSA level of ≤ 20 ng/ml
- Clinical stage ≤ T2b disease
- Life expectancy of ≥ 10 years
- Men with a prostate size ≤ 5 cm in sagittal length and ≤ 6 cm in axial length
You likely can't join if
- Unfit for general anesthesia or radical surgery
- Low volume low-risk disease (≤4mm Gleason score of ≤ 6 / ISUP grade 1)
- High-risk disease (Gleason score of ≥ 8 / ISUP grade \>3)
- Clinical T3 disease (extracapsular PCa)
- Men who have received previous active therapy for PCa.
- Men with evidence of extraprostatic disease.
See the full eligibility criteria
- Gleason score of 7 (3 + 4 or 4 + 3; ISUP grade 2/3)
- PSA level of ≤ 20 ng/ml
- Clinical stage ≤ T2b disease
- Life expectancy of ≥ 10 years
- Men with a prostate size ≤ 5 cm in sagittal length and ≤ 6 cm in axial length
- Fit, eligible, and normally destined for radical surgery or radiotherapy
- No concomitant cancer
- No previous treatment of their prostate
- An understanding of the Dutch language sufficient to receive written and verbal information about the trial, its consent process and the study questionnaires
- Unfit for general anesthesia or radical surgery
- Low volume low-risk disease (≤4mm Gleason score of ≤ 6 / ISUP grade 1)
- High-risk disease (Gleason score of ≥ 8 / ISUP grade \>3)
- Clinical T3 disease (extracapsular PCa)
- Men who have received previous active therapy for PCa.
- Men with evidence of extraprostatic disease.
- Men with an inability to tolerate a transrectal ultrasound.
- Cardiac pacemaker
- Metal implants/stents in the urethra or prostate.
- ASA ≥4
- Prostatic calcification/cysts that interfere with effective delivery of TULSA/HIFU based on MRCT.
- Men with renal impairment and a glomerular filtration rate (GFR) of \< 30 ml/minute/1.73 m2.
- Unable to give consent to participate in the trial, as judged by the attending clinicians
The study team makes the final eligibility decision.
Where it's taking place
- Nijmegen, Gelderland, Netherlands
- Etten-Leur, North Brabant, Netherlands
- Amsterdam, North Holland, Netherlands
- Zwolle, Overijssel, Netherlands
- Nieuwegein, Utrecht, Netherlands
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nijmegen, Gelderland, Netherlands; Etten-Leur, North Brabant, Netherlands; Amsterdam, North Holland, Netherlands; Zwolle, Overijssel, Netherlands; Nieuwegein, Utrecht, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.